Osteoarthritis knee orthosis

ABSTRACT

A polycentric hinge is positioned on one side of the patient&#39;s knee and a unicentric hinge is positioned on a second side of the knee. A lower portion of the polycentric and unicentric hinge is attached to a knee cuff about a lower leg of the patient. An upper arm of the polycentric and unicentric hinge is attached to a thigh cuff, the upper arm of the unicentric hinge being longer than the upper arm of the polycentric hinge. The upper arm of the unicentric hinge has a 15° to 20° set back angle when the patient&#39;s leg is straight. The polycentric hinge has a slotted central plate with star gears engaging a back portion and multiple movable blocks mounted in screw holes on a front edge of the slotted plate supporting an elastic band having a fulcrum point on the polycentric hinge at a lower and upper end.

PRIOR APPLICATIONS

This application is a division of U.S. nonprovisional application Ser.No. 11/556,557, filed on Nov. 3, 2006.

FIELD OF THE INVENTION

The invention relates to knee braces. More particularly, it refers to anoffset double upright knee brace.

BACKGROUND OF THE INVENTION

Orthotic devices and appliances commonly referred to as “orthotics,”have been utilized for many years by orthotists, physical therapists,and occupational therapists to assist in the rehabilitation of patient'sjoints and associated limbs or adjacent skeletal parts of the patient'sbody.

Webster's New College Dictionary defines “orthotics” as a branch ofmechanical and medical science that deals with the support and bracingof weak or ineffective joints or muscles.

Orthotics or limb braces have been designed to support and protect thejoint, alleviate pain associated with joint movement, and torehabilitate the joint over time with orthotic use.

Primary osteoarthritis is usually related to aging. With aging, thewater content of the cartilage increases and the protein makeup of thecartilage degenerates. Repetitive use of the joints over the years canirritate and inflame the cartilage, causing joint pain and swelling.Eventually, cartilage begins to degenerate by flaking or forming tinycrevasses. In advanced cases, there is a total loss of cartilage cushionbetween the femur and tibia bones at the knee joint, leading todiminished joint space on the affected side of the knee resulting inpain and limitation of joint mobility. Inflammation of the cartilagealso can stimulate new bone outgrowths (spurs) to form around the jointscausing increased pain and joint inflammation.

Osteoarthritis is often described as “wear and tear” arthritis, as it ishighly correlated to age. Osteoarthritis is one of the most frequentcauses of physical disability among adults. More than 20 million peoplein the US have the disease. By 2030, 20 percent of Americans, about 70million people, will have passed their 65^(th) birthday and will be atrisk for osteoarthritis.

Osteoarthrosis is a condition where the joint is affected bydegeneration. Osteoarthritis implies the same meaning, but the “itis”adds the meaning that the joint is inflamed. The two terms are oftenused interchangeably.

Joint replacement surgery of the knee is the surgical treatment forosteoarthrosis or osteoarthritis. It is best to delay knee jointreplacement surgery as long as possible, as a total knee replacement mayneed to be replaced in ten to twenty years. It is a major surgery whichrequires considerable rehabilitation therapy to restore full function.

Exercise, weight loss if needed, and the use of anti-inflammatorymedications and analgesics are often prescribed to assist the patient inmanaging the pain associated with osteoarthritis. Minimizing theprogression of the damage to the cartilage of the knee joint andpreventing the formation of bone spurs from “bone on bone” during kneejoint bending is an important part of patient care.

The actual pain of osteoarthritis or osteoarthrosis comes from wearingaway of the soft cartilage that pads the junction of the femur (upperleg bone of the knee) and the tibia (lower leg bone of the knee). Withirritation of the joint, bone spurs can form causing bits of bone andcartilage to break off which float inside the joint space furtherirritating the knee. The most common form of osteoarthritis orosteoarthrosis is unicompartmental, meaning that only one of the threecompartments of the knee joint are significantly affected by the loss ofcartilage padding. The medial compartment of the knee is on the insideof the center line of the body. The lateral compartment of the knee ison the outside plane of the body, and the patellar compartment is in thecenter top of the knee behind the patella or knee cap. The majority ofcases of osteoarthritis are medial compartment degeneration where thecartilage or cushioning of the knee joint has significantlydeteriorated. The knee then becomes imbalanced, with the knee bowingoutwards. This is often called a “bowleg” condition. A “bowleg” (genuvarum), commonly referred to as a varus deformity of the knee joint,places significant force on the medial compartment of the knee, whichaggravates the pain associated with osteoarthritis when the patientwalks, bends the knee, or stands up.

As the cartilage or padding of the knee joint on the lateral compartmentcartilage is worn away, the knee will deform abnormally bending inwardsat the knee joint giving the patient a knock kneed appearance. This isreferred to as a valgus deformity of the knee joint.

Osteoarthritis knee braces are designed to do two things: first, correctthe abnormal bending of the knee joint inwards or outwards (varus orvalgus correction). Secondly, many osteoarthritis knee orthotics orbraces are designed to prevent the “bone on bone” contact of the femurand tibia bones in the medial or lateral compartment of the knee jointas the patient bears weight during ambulation. This action of liftingfemur, pulling down the tibia or keeping the femur and tibia bones fromcoming in contact during the straightening of the knee during heelstrike is often called “unloading” the knee joint. By “unloading” theknee joint, the constant irritation of the degenerated cartilage in theaffected compartment of the knee (medial or lateral) can lead to asignificant reduction in pain and further injury to the knee joint.Osteoarthritis knee braces also provide improved alignment of the upperand lower aspects of the knee joint by preventing the bending inwards oroutwards of the knee joint during gait. These two features, unloadingand alignment are provided by most of the osteoarthritis knee orthoticsavailable in today's market.

The majority of knee orthotics available to treat osteoarthritis of theknee utilizes a single upright attached to an upper thigh cuff and lowershin cuff. The upright is located on the side of the collapsedcompartment of the knee; i.e. medial side for medial compartmentosteoarthritis. The attached cuffs “offload” the biomechanical force onthe affected compartment of the knee by increasing the joint space onthe affected side as the knee goes from flexion to extension. Manyosteoarthritis braces use an angled strap from the upper part of thebrace that goes across the opposite side of the knee joint from the sidebar or upright to improve the alignment of the knee during ambulation tobetter balance the forces on the knee during gait more evenly. The strapprovides a three point leverage that pulls the knee joint into properalignment during gait. A combination of the single sided upright withcuff attachments and the valgus producing strap have shown to provideimproved performance in severe genu varum osteoarthritis. However, it isdifficult to set the desired degrees of flexion and extension.

Although many of the existing knee braces containing locking hingeassemblies serve their intended purpose, difficulty in ease of settingthe desired degrees of flexion and extension continues to be a problem.

SUMMARY OF THE INVENTION

The present invention provides an osteoarthritis knee orthosis easilyfabricated in a wide range of sizes for either knee (left or right) totreat either medial or lateral (varus or valgus) unicompartmentaldegeneration of the knee joint caused by osteoarthritis orosteoarthrosis with easily managed controls for setting the desireddegree of flexion and extension. The knee orthosis of this inventionwill unload the pressure on the affected side of the knee joint, providebalanced joint space on both sides of the knee during ambulation,improve knee joint alignment, and can be adjusted as the condition ofthe knee improves or deteriorates to maintain joint space balance, anunloading effect on the affected side of the knee joint, and improvedknee joint alignment during gait.

As alignment of the knee changes (joint space balance), the mechanism ofthe knee brace is adjusted by this invention so that joint space balanceis continually maintained with joint rehabilitation. The currentinvention achieves this significant improvement with an adjustabledynamic fulcrum to allow the clinician to quickly and easily adjust thebrace to maintain joint space balance as needed during the kneerehabilitation process.

The present invention accomplishes the desired result of joint spacebalance by providing a lateral polycentric hinge and a medial unicentrichinge component positionable respectively laterally and mediallyadjacent the knee joint. A rigid cuff is circumscribable about the frontof the lower leg. The lower member of each hinge is attached to alateral and medial upright element respectively integral with the rigidcuff. A semi-rigid thigh cuff is aligned with the back of a patient'sthigh, above the knee joint. The thigh cuff has a lateral and medialelement extending downwardly to engage a top hinge arm of the lateraland medial hinge respectively. The top medial hinge arm is longer than acorresponding top lateral hinge arm. The top medial hinge arm is fixedat a posterior angle of about 15° to 20° in full knee extension. Aspring loaded adjustable fulcrum polycentric lateral hinge component isused to assist during leg extension-flexion during walking, squattingand sitting. By moving setting blocks different degrees of tension isintroduced into the polycentric lateral hinge.

BRIEF DESCRIPTION OF THE DRAWINGS

This invention can be best understood by those having ordinary skill inthe art by reference to the following detailed description, whenconsidered in conjunction with the accompanying drawings in which:

FIG. 1 is a lateral side perspective view of the hinge assembly of thisinvention including the attachment strapping;

FIG. 2 is a medial side perspective view of the hinge assembly of FIG.1;

FIG. 3 is a front view of a knee with a hidden view of the patella outof alignment;

FIG. 4 is a front view of a knee with a hidden view of the patella withthe knee brace of this invention in place;

FIG. 5A is a lateral side view of the hinge assembly of FIG. 1 on anextended leg of a patient;

FIG. 5B is a lateral side view of the hinge assembly of FIG. 5A with thepatient's knee in a bent position;

FIG. 6A is a lateral side view of the hinge assembly of FIG. 1 on anextended leg of a patient with only two setting blocks in place;

FIG. 6B is a lateral side elevational view according to FIG. 6A with thepatient's knee bent;

FIG. 7A is a lateral side view of the hinge assembly of FIG. 1 on anextended leg of a patient with only one setting block in place;

FIG. 7B is a lateral side according to FIG. 7A with the patient's kneebent;

FIG. 8A is a lateral side view according to FIG. 1 on an extended leg ofa patient with the setting blocks moved to an extreme position;

FIG. 8B is a lateral side view according to FIG. 8A with the patient'sknee bent.

DETAILED DESCRIPTION OF THE INVENTION

Throughout the following detailed description the same referencenumerals refer to the same elements in all figures.

Referring to FIGS. 1 and 2, the osteoarthritis knee orthosis 10(hereafter identified as OA), has a medial unicentric hinge 12 withflexion stop 14 and extension stop 16 at any setting. The medialunicentric hinge 12 is substantially parallel to a lateral polycentricadjustable tension offloading hinge 18. The bottom end 20 of medialhinge 12 is attached to a first upright member 22 integral with a kneering 24. A lower gear plate 26 of lateral hinge 18 is attached to asecond upright member 28 integral with knee ring 24.

An upper arm 30 of the lateral hinge 18 connects at an upper end to aflexible upper thigh cuff 32. A lower portion of the lateral hingebroadens out to a slotted hinge connector plate 34. A slot 36, inconnector plate 34 contains a transverse shaft on rivet 40. The rivet 40attaches a first star gear 42 to an inside surface of the slottedconnector plate 34. A second star gear 43 is integral with a gear plate44 attached to an inner surface of upper arm 30.

An upper arm 48 of the medial hinge 12 is attached at its top end 50 tothe flexible upper thigh cuff 32. Medial hinge 12 is a KWIK-SET designset forth in U.S. Pat. No. 6,039,709, incorporated herein by reference.The upper arm 48 of medial hinge 12 is significantly longer than theupper arm 30 of the lateral hinge set 18; about 1½ inches in the mediumsize. The longer length of medial upper arm 48 compared to the upper arm30 of the lateral hinge 18 encourages unloading of force from the medialcompartment of the knee by lifting the medial side 52 of the femur 54off of the tibia 56 with weight bearing during full leg extension. Seethe gap 58 shown in FIG. 4.

The lower medial side upright 22 and lower lateral side upright 28 areequivalent in length. The medial upper arm 48 is set back at an angle ofapproximately 15° to 20° with the leg straight whereas upper lateral arm30 and lower lateral upright 28 are in a relatively straight alignmentwith the hinge when the leg is straight. The offset portion of arm 48improves knee alignment from 20° of flexion to full extension of theknee joint and prevents “reverse Screw Home Mechanism” rotation of theknee.

As shown, the various elements are held together by rivets such as rivet40. Other equivalent means of attachment could be substituted for therivets.

On polycentric hinge 18, an elastic band 60 attaches at a lower end onthe outside of the second upright member 28 at fulcrum point 70 andtravels adjacent adjustable dynamic fulcrum setting blocks 62, 64 and 66to terminate at fulcrum 68. The dynamic tension of the fulcrum 68 can beset by the fitter by using fulcrum blocks 62, 64 and 66. In addition,various elastic bands 60 with varying elastic properties can besubstituted to allow the fitter to adjust the dynamic fulcrum withmultiple tension forces. The dynamic adjustable fulcrum is derived fromthe band 60 positioned from the lower fulcrum point 70, and stretchedover blocks 62, 64 and 66 at the lateral hinge as the knee bends. SeeFIG. 5B. The adjustable dynamic fulcrum is used to provide a dynamictension force at the knee joint that can be used to balance the jointspace 58 between the medial and lateral compartments and to provideoptimal alignment of the knee with the OA 10 brace.

FIGS. 6A and 6B show alignment using only two blocks, 62 and 64, on thepolycentric hinge 18.

FIGS. 7A and 7B show minimal alignment using only one block 62 on thepolycentric hinge 18.

FIGS. 8A and 8B show an extreme alignment using blocks 64, 66 and 67. Inthis condition there is no block 62 in lower aperture 98 on thepolycentric hinge 18.

A strap 72 tightens thigh cuff 32 in place.

A second mid-thigh cuff securing strap 78 is a soft elastic materialwith a soft adjustable pad 74 placed at the inner midpoint area of strap78. Strap 72 is placed through a D-ring fastener 76 on the side of thethigh cuff 72. Hook and loop material is used to engage strap 72 toitself. Soft padded mid-thigh securing strap 78 travels from the lateralside of OA 10 through a second D-ring fastener 80 on the medial side ofOA 10. The strap 78 fastens to itself by hook and loop material.

A shin cuff soft elastic material securing strap 82 travels across theback of the patient's calf through a third D-ring fastener 84 on thelower end of the lateral upright 28 and fastens onto itself with hookand loop material. A padded calf strap 86 travels around the back of thecalf with an adjustable pad 88 located at mid strap 86. Strap 86 passesthrough a D-ring fastener 93 on the lower upright 28 and is attached toitself by hook and loop material.

The knee brace bends with free moving axial hinges, each with sixequivalently sized axial teeth on the upper and lower aspects of theinner hinge assembly of the medial and lateral hinges 12 and 18. As theknee bends, the bend movement is tracked or guided by the rigid braceuprights at the hinge center axle through groove 36 on the lateralhinge. The hinge alignment forces the bend line of the brace throughgrooves 36 that is pre-cut into the lateral hinge 18. The specific bendmovement of the knee is controlled by the hinge axle traveling throughthe grooves 36 in the lateral hinge 18. The adjustable dynamic fulcrumon the lateral hinge 18 can be set to provide a dynamic assist mechanism62, 64 and 66 with spring band 60 to assist in controlling the alignmentand movement of the knee from 20° of flexion to full extension of theknee. The adjustable properties of the dynamic fulcrum offer the fitteror wearer multiple settings to maintain knee joint space balance,improved knee joint alignment, and prevention of “reverse Screw HomeMechanism” or controlled rotation of the knee as the knee goes from 20°flexion to extension.

The adjustable dynamic fulcrum band mechanism 60 is on the lateralupright of the OA Knee Brace 10 for medial compartment osteoarthritis.Four threaded holes 92, 94, 96 and 98 are arranged along the hinge ofthe outer lateral connector plate 34. Blocks 62, 64, 66 and 67 arescrewed into the holes as needed. Block 64 can be inserted in hole 96providing the center point of the elastic band fulcrum as the knee bendsif the optimal dynamic setting of the adjustable pull mechanism isneeded. A second block 62 with elastic band 60 tracking material can beinserted into threaded hole 98 if another optimal dynamic setting of theadjustable pull mechanism is needed. A third adjustable dynamic fulcrummechanism is available by inserting block 66 with the elastic band 60tracking material into threaded hole 94. By providing three or moreincrementally stronger or more elastic bands, the fitter will havemultiple settings to adjust the dynamic fulcrum to maintain the correctamount of dynamic force to maintain optimal joint space on both themedial and lateral compartments of the knee as well as to maintainoptimal knee alignment during the motion of the knee during ambulation.

Other equivalent elements can be substituted for the elements disclosedherein to produce the same results in the same way.

1. In a knee orthosis device having a double upright strut designattached to upper and lower cuff members of said knee orthosis forsecuring said knee orthosis to a knee joint area of a patient, a dynamicgait swing assist mechanism comprising an adjustable dynamic fulcrumhaving an upper and lower fulcrum point, each of the upper and lowerpoints attaching opposing ends of an elastic band, the elastic bandstretching over at least one fulcrum setting block of the dynamic gaitswing assist mechanism.
 2. The dynamic gait swing assist mechanism ofclaim 1, wherein the elastic band is interchangeable with variouselastic bands having a plurality of elastic properties.
 3. The dynamicgait swing assist mechanism of claim 1, wherein the at least one fulcrumsetting block includes four setting blocks.
 4. The dynamic gait swingassist mechanism of claim 3, wherein the four setting blocks areinterchangeable to provide a multitude of various setting tensions, andthe four blocks including first setting block, second setting block,third setting block and fourth setting block.
 5. The dynamic gait swingassist mechanism of claim 4, wherein the four setting blocks can beemployed in various combinations to include, the first, second, thirdand fourth setting blocks, the first, second and third setting blocks,the first, second and fourth setting blocks, the first, second and thirdsetting blocks, the first and second setting blocks, the first and thirdsetting blocks, the first and fourth setting blocks, the second, thirdand fourth setting blocks, the second and fourth setting blocks, thethird and fourth setting blocks, just the fourth setting block, just thethird setting block, just the second setting block, and just the firstsetting block.
 6. The dynamic gait swing assist mechanism of claim 1,wherein the knee orthosis is used to treat osteoarthritis of the kneejoint.
 7. The dynamic gait swing assist mechanism of claim 6, whereinthe osteoarthritis of the knee joint is chosen from the group consistingof medial compartmental osteoarthritis, lateral compartmentalosteoarthritis and patella compartmental osteoarthritis.
 8. The dynamicgait swing assist mechanism of claim 1, wherein the adjustable dynamicfulcrum is mounted either on the medial or lateral side of the kneejoint area.
 9. The dynamic gait swing assist mechanism of claim 1,further comprising the knee orthosis having a polycentric hinge and auni-centric hinge intermediately employed along one each of the twoupright struts.
 10. The dynamic gait swing assist mechanism of claim 9,wherein the adjustable dynamic fulcrum is mounted along the kneeorthosis polycentric hinge.
 11. The dynamic gait swing assist mechanismof claim 1, wherein the adjustable dynamic fulcrum assists incontrolling the alignment and movement of the knee joint from 20° offlexion to full extension.
 12. The dynamic gait swing assist mechanismof claim 1, wherein the double upright struts of the knee orthosis areoff-set.
 13. In a knee orthosis device having a double upright strutdesign attached to upper and lower cuff members of said knee orthosisfor securing said knee orthosis to a knee joint area of a patient, adynamic gait swing assist mechanism comprising means for improving kneejoint extension during gait.
 14. The dynamic gait swing assist mechanismof claim 13, wherein the means for improving knee joint extension duringgait is an adjustable dynamic fulcrum having an elastic band stretchedover at least one setting block along a hinge element of the kneeorthosis.
 15. In a knee orthosis device having a double upright strutdesign attached to upper and lower cuff members of said knee orthosisfor securing said knee orthosis to a knee joint area of a patient, adynamic gait swing assist mechanism comprising means for maintainingjoint space balance within the knee joint area during gait.
 16. Thedynamic gait swing assist mechanism of claim 15, wherein the means formaintaining joint space balance within the knee joint area alignmentduring gait is an adjustable dynamic fulcrum having an elastic bandstretched over at least one setting block along a hinge element of theknee orthosis.
 17. In a knee orthosis device having a double uprightstrut design attached to upper and lower cuff members of said kneeorthosis for securing said knee orthosis to a knee joint area of apatient, a dynamic gait swing assist mechanism comprising means forproviding a dynamic tension force at the knee joint area during gait.18. The dynamic gait swing assist mechanism of claim 17, wherein themeans for providing a dynamic tension force at the knee joint areaduring gait is an adjustable dynamic fulcrum having an elastic bandstretched over at least one setting block along a hinge element of theknee orthosis.
 19. In a knee orthosis device having a double uprightstrut design attached to upper and lower cuff members of said kneeorthosis for securing said knee orthosis to a knee joint area of apatient, a dynamic gait swing assist mechanism comprising means forpreventing reverse screw home mechanism or for controlling rotation ofthe knee joint as it goes from flexion to extension.
 20. The dynamicgait swing assist mechanism of claim 19, wherein the means forpreventing reverse screw home mechanism or for controlling rotation ofthe knee joint as it goes from flexion to extension is an adjustabledynamic fulcrum having an elastic band stretched over at least onesetting block along a hinge element of the knee orthosis.